Quality Engineer

Quality Engineer

Job Title: Quality Engineer
Contract Type: Permanent
Location: Wicklow
Salary: Negotiable
Start Date: ASAP
Reference: HQ00054226_1489590151
Contact Name: Rachel Radford
Contact Email:
Job Published: March 15, 2017 15:02

Job Description

Key Responsibilities:

Reporting to the Quality Engineering and Product Release Manager, the successful candidate will be responsible for providing guidance on all aspects of quality, and quality engineering within a cross functional team thus ensuring customer satisfaction and reduction of scrap.

Key Responsibilities:

  • Support Operations through the product life cycle / process for defined product portfolios
  • Management of process deviations, non-conformances, reworks, CAPA, Design Changes, complaints, scrap and change requests for product group
  • Lead Validation activities for designated product groups
  • Conduct process and GMP audits and ensure area compliance
  • Liaise with regulatory department to ensure product supply is maintained and all quality aspects are met
  • Champion QA and continuous improvement initiatives

Required Experience:

  • Graduate in a science, engineering or related background.
  • 3-5 years in a QA Engineering / QE Experience, working within a recognised quality system within IVD, Medical Device or Pharma industry.
  • 2-3 years validation experience in equipment/process/software is highly desirable.
  • A working knowledge of regulatory requirements.
  • A technical background or knowledge of IVD products or Medical devices would be advantageous.
  • Awareness of statistical techniques and validation.
  • Experience of internal, third party regulatory & external customer audits.
  • In-depth knowledge of International Standards, GLP and GMP

If you are interested in this position, please don't hesitate to apply!

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